An observational study in Esophageal Cancer, Surgery Indication and Malnourished, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University Hospital, Bordeaux · Observational
Malnutrition is common at the time of diagnosis of esogastric cancers. However, there are no recommendations regarding preoperative nutritional support (type and duration) or on the impact of refeeding on postoperative morbidity and mortality.
Malnutrition is frequently associated with esogastric cancers at diagnosis (65-80% of cases). It has been shown that malnutrition in digestive oncology is linked to increased mortality, higher rates of postoperative complications, greater toxicity induced by chemoradiotherapy, and reduced survival. Furthermore, malnutrition present before the start of neoadjuvant treatment is likely to worsen during therapy, due to the occurrence of diarrhea, malabsorption, and dysgeusia during chemotherapy.
However, there are no recommendations regarding the use of nutritional support (type and duration) during the neoadjuvant treatment phase for esogastric cancers. Indeed, the data in the literature are quite heterogeneous regarding the duration of preoperative nutrition, ranging from a few days to several weeks, as well as the type of nutritional support to be used. No study has specifically investigated the evolution of nutritional status during this refeeding phase. As for postoperative complications, the results are mixed, although the trend suggests a reduction in postoperative complications for esophageal surgery. For gastric surgery, only one study examined surgical site infections and found a decrease in incidence when adequate nutrition was provided for more than 14 days before surgery. Nevertheless, postoperative mortality was not affected by improved nutritional status. Most of these studies are small retrospective series. The only prospective studies assessed preoperative nutrition for just 7 days before surgery, with limited sample sizes.
An educational review was published in 2012 highlighting the importance of nutritional support in malnourished patients, recommending nutritional supplementation for all patients: oral supplementation for non-malnourished patients, and jejunostomy feeding for malnourished patients.
In this context, the primary objective of this study is to evaluate the rate of postoperative complications with perioperative enteral nutrition compared to the absence of preoperative enteral nutrition.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's planned enrollment of 670 is above the median of 200 across 432 observational studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Retrospective case-control study including patients with esophageal cancer treated with neoadjuvant therapy.
The control group consists of patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
The case group consists of patients who received enteral or parenteral nutrition during neoadjuvant treatment.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
patients who received enteral or parenteral nutrition during neoadjuvant treatment.
Dietary Supplement: Enteral or parenteral nutrition
Patients who did not receive enteral or parenteral nutrition during neoadjuvant treatment.
Rate of postoperative complications according to the Clavien classification
Proportion of patients experiencing at least one postoperative complication, classified according to Clavien-Dindo, in malnourished patients with versus without nutritional support.
Time frame: Day 30
Plan to share: Yes — Data access via extraction from the national FREGAT database.
Supporting information: Study protocol, Statistical analysis plan
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